Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer

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Measure Information	2023 Performance Period	2024 Performance Period	2025 Performance Period
Title	Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer	Intravesical Bacillus-Calmette-Guerin for non-muscle invasive bladder cancer	Intravesical Bacillus-Calmette-Guerin for Non-Muscle Invasive Bladder Cancer
CMS eCQM ID	CMS646v3	CMS646v4	CMS646v5
CBE ID*	Not Applicable	Not Applicable	Not Applicable
MIPS Quality ID	481	481	481
Measure Steward	Oregon Urology	Oregon Urology	Oregon Urology
Description	Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of bladder cancer staging	Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of bladder cancer staging	Percentage of patients initially diagnosed with non-muscle invasive bladder cancer and who received intravesical Bacillus-Calmette-Guerin (BCG) within 6 months of bladder cancer staging
Measure Scoring	Proportion measure	Proportion measure	Proportion measure
Measure Type	Process	Process	Process
Stratification	*See CMS646v3.html	None	None
Risk Adjustment	*See CMS646v3.html	None	None
Rationale	*See CMS646v3.html	Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, there were an estimated 699,450 people living with bladder cancer in... the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020). National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2020) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high risk and are similarly treated with adjuvant intravesical therapy with BCG being a Category 1 recommendation. (NCCN, 2020). Show more > Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, there were an estimated 699,450 people living with bladder cancer in the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020). National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2020) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high risk and are similarly treated with adjuvant intravesical therapy with BCG being a Category 1 recommendation. (NCCN, 2020). Show less	Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, there were an estimated 699,450 people living with bladder cancer in... the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020). National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2021) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high risk and are similarly treated with adjuvant intravesical therapy with BCG being a Category 1 recommendation. (NCCN, 2021). Show more > Bladder cancer is ranked 10th for new cancer cases in 2020 and is the 9th leading cause of cancer death in the United States. There are 81,400 estimated new cases in 2020 and 17,980 estimated deaths in 2020. In 2016, there were an estimated 699,450 people living with bladder cancer in the United States. Early detection (discovery of cancer in situ or localized to the primary site) is found in 85% of the patients, and with these there is a five-year survival rate of 95.8% for In Situ and 69.2% for Localized. Bladder cancer is rarely found in patients under age 20, with the median age of diagnosis being 73 (NIH, 2020). National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (version 6.2021) defines intravesical BCG as Category 1 Treatment for Ta - high grade, T1 and Tis non-muscle invasive bladder cancer. Most public data reflects prophylactic or adjuvant use of intravesical therapy with the goal of preventing recurrence or delaying progression to a higher grade or stage. BCG has been shown to be effective as prophylaxis to prevent bladder cancer recurrences following TURBT. The NCCN Bladder Cancer Panel Members recommend BCG as the preferred option over Mitomycin C for adjuvant treatment of high-grade lesions (Ta). BCG is also standard therapy for Primary Tis. Most T1 lesions are high risk and are similarly treated with adjuvant intravesical therapy with BCG being a Category 1 recommendation. (NCCN, 2021). Show less
Clinical Recommendation Statement	*See CMS646v3.html	Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization,... bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and American Urological Association (AUA) Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS). Show more > Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization, bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and American Urological Association (AUA) Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS). Show less	Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization,... bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and American Urological Association (AUA) Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS). Show more > Intravesical BCG should be administered within 6 months of the initial diagnosis of non-muscle invasive bladder cancer. It may be administered 3-4 weeks after resection, but there needs to be pathological tumor confirmation and must be withheld if there is traumatic catheterization, bacteriuria, persistent gross hematuria, persistent severe local symptoms or systemic symptoms. The normal induction course is 6 weekly instillations of intravesical BCG (AUA Non-Muscle Invasive Bladder Cancer and American Urological Association (AUA) Guideline for the Management of Non-muscle Invasive Bladder Cancer: Stages Ta High Risk, T1 and TIS). Show less
Improvement Notation	A higher score is the preferred result and indicates better quality	A higher score is the preferred result and indicates better quality	A higher score is the preferred result and indicates better quality
Definition	*See CMS646v3.html	Intravesical - Within the urinary bladder Bacillus Calmette-Guerin (BCG) - A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970's. Tumor location: urinary bladder Histology: urothelial... carcinoma Primary Tumor (T) stage: Ta - Noninvasive and high grade Tis - Carcinoma in situ: "flat tumor" T1- tumor invades subepithelial connective tissue (high grade or low grade) Show more > Intravesical - Within the urinary bladder Bacillus Calmette-Guerin (BCG) - A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970's. Tumor location: urinary bladder Histology: urothelial carcinoma Primary Tumor (T) stage: Ta - Noninvasive and high grade Tis - Carcinoma in situ: "flat tumor" T1- tumor invades subepithelial connective tissue (high grade or low grade) Show less	Intravesical - Within the urinary bladder Bacillus Calmette-Guerin (BCG) - A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970's. Tumor location: urinary bladder Histology: urothelial... carcinoma Primary Tumor (T) stage: Ta - Noninvasive and high grade Tis - Carcinoma in situ: "flat tumor" T1- tumor invades subepithelial connective tissue (high grade or low grade) Show more > Intravesical - Within the urinary bladder Bacillus Calmette-Guerin (BCG) - A live attenuated strain of Mycobacterium bovis, first indicated as a tuberculosis vaccine, has had widespread use in intravesical immunotherapy since the 1970's. Tumor location: urinary bladder Histology: urothelial carcinoma Primary Tumor (T) stage: Ta - Noninvasive and high grade Tis - Carcinoma in situ: "flat tumor" T1- tumor invades subepithelial connective tissue (high grade or low grade) Show less
Guidance	Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure... because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show more > Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show less	Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure... because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show more > Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show less	Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure... because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show more > Ta bladder cancer must be high grade Ta only and is supported by the 2016 AUA guidelines and 2018 NCCN guidelines. The BCG dose can be full or partial and can be from any lot or manufacturer. This eCQM is a patient-based measure. Telehealth encounters are not eligible for this measure because the measure requires a clinical action that cannot be conducted via telehealth. This version of the eCQM uses QDM version 5.6. Please refer to the QDM page for more information on the QDM. Show less
Initial Population	All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer and a qualified encounter in the measurement period	All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer with bladder cancer staging within 6 months before to 6 months after the start of the measurement period and a qualified encounter in the measurement period	All patients initially diagnosed with T1, Tis or high grade Ta non-muscle invasive bladder cancer with bladder cancer staging within 6 months before to 6 months after the start of the measurement period and a qualified encounter in the measurement period
Denominator	Equals Initial Population	Equals Initial Population	Equals Initial Population
Denominator Exclusions	Immunosuppressed patients, includes HIV and immunocompromised state. Immunosuppressive drug therapy. Active Tuberculosis. Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease. Patients who undergo cystectomy,... chemotherapy or radiation within 6 months of Bladder Cancer Staging. Show more > Immunosuppressed patients, includes HIV and immunocompromised state. Immunosuppressive drug therapy. Active Tuberculosis. Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease. Patients who undergo cystectomy, chemotherapy or radiation within 6 months of Bladder Cancer Staging. Show less	Immunosuppressed patients, includes HIV and immunocompromised state, with a diagnosis prior to Bladder Cancer Staging Immunosuppressive drug therapy starting on or before Bladder Cancer Staging Active Tuberculosis diagnosis during the Bladder Cancer Staging Mixed histology urothelial cell... carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease prior to Bladder Cancer Staging Patients who undergo cystectomy, chemotherapy or radiation within 6 months of Bladder Cancer Staging Show more > Immunosuppressed patients, includes HIV and immunocompromised state, with a diagnosis prior to Bladder Cancer Staging Immunosuppressive drug therapy starting on or before Bladder Cancer Staging Active Tuberculosis diagnosis during the Bladder Cancer Staging Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease prior to Bladder Cancer Staging Patients who undergo cystectomy, chemotherapy or radiation within 6 months of Bladder Cancer Staging Show less	Immunosuppressed patients, includes HIV and immunocompromised state, with a diagnosis prior to Bladder Cancer Staging. Immunosuppressive drug therapy starting on or before Bladder Cancer Staging. Active Tuberculosis diagnosis during the Bladder Cancer Staging. Mixed histology urothelial... cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease prior to Bladder Cancer Staging. Patients who undergo cystectomy, chemotherapy or radiation within 6 months prior to Bladder Cancer Staging. Show more > Immunosuppressed patients, includes HIV and immunocompromised state, with a diagnosis prior to Bladder Cancer Staging. Immunosuppressive drug therapy starting on or before Bladder Cancer Staging. Active Tuberculosis diagnosis during the Bladder Cancer Staging. Mixed histology urothelial cell carcinoma including micropapillary, plasmacytoid, sarcomatoid, adenocarcinoma and squamous disease prior to Bladder Cancer Staging. Patients who undergo cystectomy, chemotherapy or radiation within 6 months prior to Bladder Cancer Staging. Show less
Numerator	Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series BCG is initiated within 6 months of the bladder cancer staging and during the measurement period	Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer staging	Intravesical Bacillus-Calmette Guerin (BCG) instillation for initial dose or series: BCG is initiated within 6 months of the bladder cancer staging
Numerator Exclusions	Not Applicable	Not Applicable	Not Applicable
Denominator Exceptions	Unavailability of BCG	Unavailability of BCG within 6 months after Bladder Cancer Staging	Unavailability of BCG within 6 months after Bladder Cancer Staging
Telehealth Eligible	No	No	No
Next Version	No Version Available	CMS646v5	No Version Available
Previous Version	No Version Available	CMS646v3	CMS646v4

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Additional Resources for CMS646v3

CMS646v3-TRN.xlsx

Header

Updated copyright.
Measure Section: Copyright
Source of Change: Annual Update
Updated citations to align with APAv6 Style Guide standards.
Measure Section: Rationale
Source of Change: Measure Lead
Updated references.
Measure Section: Reference
Source of Change: Measure Lead
Updated version number of the Quality Data Model (QDM) used in the measure specification to v5.6.
Measure Section: Guidance
Source of Change: Standards/Technical Update
Updated grammar, punctuation, and formatting to improve readability.
Measure Section: Multiple Sections
Source of Change: Measure Lead

Logic

Restructured denominator exclusion definitions into a group to streamline by combining definitions with the same timing.
Measure Section: Definitions
Source of Change: Measure Lead
Removed one set of open brackets from each exclusion definition to comply with the CQL Style Guide.
Measure Section: Definitions
Source of Change: Measure Lead
Revised timing from 'end Measurement Period' to 'end of Measurement Period' in the 'Bladder Cancer Diagnoses' definition to improve readability.
Measure Section: Definitions
Source of Change: Measure Lead
Replaced 'Bladder Cancer Diagnoses' definition in the initial population with 'First Bladder Cancer Staging Procedure during Measurement Period' to align with measure intent to capture patients whose first bladder cancer staging occurred during the measurement period.
Measure Section: Definitions
Source of Change: Measure Lead
Updated the names of CQL definitions, functions, and/or aliases for clarification and to align with the CQL Style Guide.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Updated the version number of the Measure Authoring Tool (MAT) Global Common Functions Library to v7.0.000.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Replaced direct reference code SNOMED CT code (258232002) with direct reference code SNOMED CT code (254292007).
Measure Section: Multiple Sections
Source of Change: Measure Lead
Updated logic using the new QDM 5.6 'Encounter, Performed' class attribute to exclude telehealth (or virtual) encounters using the logical representation (class !~ virtual), for measures containing telehealth-eligible codes, where telehealth is not appropriate. For more information, please refer to the 2023 Telehealth Guidance document.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update
Updated the version of the Quality Data Model (QDM) to 5.6 and Clinical Quality Language (CQL) to 1.5.
Measure Section: Multiple Sections
Source of Change: Standards/Technical Update

Value set

The VSAC is the source of truth for the value set content, please visit the VSAC for downloads of current value sets.

Value set Immunocompromised Conditions (2.16.840.1.113883.3.666.5.1940): Deleted 1 SNOMED CT code (404145009) based on new or changed coding guidelines. Deleted 1 ICD-10-CM code (D84.8) based on new or changed coding guidelines.
Measure Section: Terminology
Source of Change: Annual Update
Replaced direct reference code SNOMED CT code (258232002) with direct reference code SNOMED CT code (254292007) based on terminology updates and review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Value set HIV (2.16.840.1.113883.3.464.1003.120.12.1003): Added 13 SNOMED CT codes based on review by technical experts, SMEs, and/or public feedback. Added 6 ICD-10-CM codes (O98.711, O98.712, O98.713, O98.719, O98.72, O98.73) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Added direct reference code ActCode code (VR) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead